Why “Reading” and “Doing Your Own Research” are not nearly enough….

 

 

Medical training is an exercise in repeatedly meeting people who know a lot more about the field than you do and hoping to learn something in the process.  It happens regularly – often several times a day.  It is a common occurrence to meet people with encyclopedic knowledge – not just of textbooks and papers but disease patterns and presentations as well as the best treatment approaches.  The knowledge can be obtained through straight didactics, informal seminars, bedside interactions, and direct observation.  It can be affiliative or adversarial. In other words, you might get the attending physician who asks you a series of questions until you run your knowledge base dry or you might get the attending who realizes that your life is difficult and details the pathophysiology while pointing you to the latest review to read.

All that dynamic learning happens in a certain time frame where everyone must focus on the problems of the day.  The recent COVID-19 epidemic is a striking case in point. During the years of my training and practice the pandemic of interest was the human immunodeficiency virus (HIV-1, HIV-2). I started to see those patients in residency training – typically for the neuropsychiatric manifestations. At the time there were full isolation precautions and we had to wear surgical gowns, caps, and masks to see the patients. There was also the concern about needlestick injuries and injuries sustained by during surgery on HIV positive patients – that was subsequently shown to be a rare occurrence.  

All primary care and specialty physicians need to have a knowledge of HIV/AIDS – because of the potential protean manifestations, the need to maintain medications, and for infection control purposes.  It is also useful to recall epidemiological and infectious disease concepts – the most relevant being that for a while the infectious agent of the disease was not known.  Early in the course it was characterized by epidemiological features. When the virus was eventually isolated – steady progress was made in the development of antivirals to the point where the virus can be suppressed and is no longer detectable.

Over the course of learning about the illness and its treatment – I observed a heavy toll on treatment providers. There were no effective treatments early on.  I had lunch every day with an infectious disease team who ran one of the early HIV/AIDS clinics. Providing care in that setting took an emotional toll on them.

Against that 40 year backdrop – Aaron Rodgers recent press conference stands in tragic contrast.  For a time, Rodgers assumed the role of inscrutable new age guru.  He refused to state his COVID vaccine status but talked in detail about the rejuvenative properties of ayahuasca.  But I want to focus on his 208-word commentary on HIV, COVID, and Dr. Fauci. The full video is linked above for viewing.  I will address his commentary on a subject-by-subject basis.

1:  There was a “game plan” in the 1980s to create a pandemic with a “virus that’s going wild.”

Multiple lines of evidence show that HIV resulted from cross species transmission of Simian Immunodeficiency Virus (SIV) existing in African primate species. The transmission occurred through infected blood or bodily fluid exposure from hunting (1).  The key concept is that many human pandemics originate from cross species transmission.  Further – there is ample evidence that the cross over to humans occurred decades before the first AIDS fatality occurred in the US in the 1980s.  The only "game plan" in place was evolution in nature - over millions of years.

2:  Dr. Fauci was given $350 million dollars to research this:

Dr. Fauci was appointed head of the National Institute of Allergy and Infectious Diseases (NIAID) in 1982. NIAID is one of 27 institutes and centers of the National Institute of Health (NIH).  The funding for AIDS research is available on several sites. In this paper Tables 4.2 and 4.3 give the research dollars as well as the distribution by institute. In 1982 for example – there was $3.6M in AIDS funding.  Looking at the 1990-1991 allocation NIAID got 53.1% of the research allocation. The detailed allocation of that grant money consists of intramural and extramural research funding as well as funding clinical centers of research with adequate patient numbers to advance the field. From that paper:

“The need for more—and more appropriate—facilities specifically for AIDS work was acutely apparent in early 1988 when NIH director James Wyngaarden and NIH AIDS coordinator Anthony Fauci testified before several congressional committees (U.S. Congress, 1988a:259, 1988c:331). Their concerns were echoed in the June 1988 report of the Presidential Commission on the HIV Epidemic. The commission noted that plans for AIDS office and lab space were seriously delayed, and recommended that intramural construction and instrumentation needs be assessed and made a high priority in future budget requests…”

When Dr. Fauci assumed control of NIAID, the total budget of that agency was $350M.  He described it as a relatively secondary institution, that he built up to a $6.3B agency over the next 38 years (3). 

3:  The only drug they came up with was AZT:

 Azidothymidine (AZT) was developed in 1964 by the National Cancer Institute (NCI) as a potential anti-cancer therapy.  It was ineffective but was included in screening as an HIV treatment where it stopped viral replication without damaging normal cells.  It was the first FDA approved drug to treat AIDS in 1987. Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) was founded at that time along with other networks though NIAID to conduct clinical trials in therapeutics for AIDS. Subsequent trials established more safe and effective doses as well as demonstrating a delayed onset of AIDS in HIV infected persons with AZT making it the first effective HIV treatment.

NIAID funded research for combination therapy, triple drug therapy and novel agents to the point where there are now 30 anti-retroviral drugs and new classes of therapeutic agents.  During Dr. Fauci’s tenure at NIAID, research has gone from antiretroviral treatment (ART) based remission to clinical trials looking at strategies for potential ART-free remission of HIV or cure (4).  That goal has not been realized but there is no question that the research work on HIV has been productive resulting in reduced transmission and mortality.

 4:  An “environment” was created where only one drug worked

The environment was a research environment looking for treatments at a time where there were so many AIDS related deaths that it led to public outcry and activism. AZT was discovered as effective in a standard screening protocol, but additional clinical trials were necessary to establish doses, safety, and efficacy for FDA approval.

5:  Just like HIV – only remdesivir worked for COVID until there was a vaccine

Just like HIV – additional therapies became available for COVID (SARS-CoV-2) including nirmatrelvir-ritonavir (Paxlovid), simnotrelvir-ritonavir, and high titer convalescent plasma.  A recent review of the issue of vaccine versus pills for COVID concludes that it is a false dilemma and that they may have complementary roles (5). There is active research continuing in SARS-CoV-2 antivirals and no reason to expect that there will not be many additional medications.

6:  Dr. Fauci had a conflict of interest because of a “stake in the Moderna vaccine.”

Dr. Fauci has no stock in Pharma companies. The “stake” in vaccines are royalty payments that researchers are obligated to take, the majority occurring before the COVID pandemic. That standard and the average payments have been documented in the medical literature where Dr. Fauci is on record as having donated payments to charity (6).  Without having a detailed list of royalty payments, what they were for, and the outcomes it is difficult to make any additional comments except to say that there was no violation of NIH policy – in fact not accepting the payments was a violation. Royalties are based on discoveries and not getting products to market, FDA approval, or sales.  My further speculation is that the royalties are a small fraction of actual sales and company profits and the original NIH policy was probably designed to retain talented researchers who would otherwise be lost to private industry. Major universities and research institutes generally allow their faculty to accept consulting and royalty fees. I have worked in several settings where those arrangements were spelled out in the initial employment contract, including intellectual property ownership.

7:  Pfizer is also “criminally corrupt” based on a fine that was paid.

Large fines against pharmaceutical companies are the rule rather than the exception.  In looking at this list of the largest settlements most of the fines are based on regulatory laws having to do with off label promotion of drugs beyond what is indicated in the FDA package insert. Practically all of the penalties have to do with marketing rather than research or production. It has been well known for decades that Pharma companies aggressively market their products to physicians, hospitals, clinics, and now direct-to-consumer advertising to potential patients. You could look at a list like this and decide against using a company’s product – but it might mean not taking a potentially safe and effective drug.  The same type of enforcement actions are taken against companies in other fields such as information technology.

8:  People who can “do their own research” and “read” are commonly vilified for that if they question authority

There is a basic difference between authority and expertise. The only vilification that I have noticed is of experts. Dr. Fauci is an extreme example but during COVID it extended to many local public health officials. It was a direct product of the minimization of COVID by President Trump and many of his officials as well as the MAGA movement.  Further it has led to political violence that includes threats of physical harm to Dr. Fauci and many other public health officials.  These threats are unprecedented and have been attributed to right wing political rhetoric.

9:  Why should science be trusted if it can’t be questioned.

Science is continuously questioned and this is probably the most significant public misunderstanding.  Science is a process where results are continuously challenged and updated. The politization of the COVID pandemic illustrates what happens when people who are not trained in the scientific method get involved. Suddenly each scientific modification means that somebody was wrong or lying. Scientists are treated like politicians and the politicians feel free to say anything that is not grounded in science. 

That is not how science works. It takes actual observations over time to test hypotheses.  As one example – I have collected about 200 hypotheses on the pathophysiology of depression over the past 40 years and to date – there are not sufficient observations to prove or disprove them and get to the level of a theory of depression. An equivalent scenario is the endless speculation of the lab leak hypotheses versus the cross-species transmission hypothesis of COVID origins.  Although the probability lies in the direction of cross species transmission – there are insufficient direct observations to prove one versus the other and ample discussions of the lab leak hypothesis by people with a complete lack of expertise.

Finally, with the errors in Rodger’s statement – I would be remiss if I did not mention Brandolini’s Law. Simply stated:

“The amount of energy needed to refute bullshit is an order of magnitude bigger than to produce it.”

This is true – especially when the false argument does not have to be based on facts, process, or rigorous standards. The politization of COVID and many other health issues by the extreme right wing should be a lesson that is not forgotten.  This video clip is a case in point.

 

George Dawson, MD, DFAPA

Supplementary 1:  The NIH policy on royalty payments to inventors can be viewed at this link.  The abbreviation IC stands for the Institutes and Centers of the NIH.  More detailed information can be found at this link.  The NIH also has conflict of interest policy (see conflict of interest in Appendix 1).

 Supplementary 2:  A few relevant titles from my library - note dates. 

 

References:

1:  Sharp PM, Hahn BH. Origins of HIV and the AIDS pandemic. Cold Spring Harb Perspect Med. 2011 Sep;1(1):a006841. doi: 10.1101/cshperspect.a006841. PMID: 22229120; PMCID: PMC3234451.

2:  Institute of Medicine (US) Committee to Study the AIDS Research Program of the National Institutes of Health. The AIDS Research Program of the National Institutes of Health. Washington (DC): National Academies Press (US); 1991. 4, Supporting the NIH AIDS Research Program. Available from: https://www.ncbi.nlm.nih.gov/books/NBK234085/

3:  Anthony Fauci: a scientific adviser's role from HIV to COVID-19. Bull World Health Organ. 2023 Jan 1;101(1):8-9. doi: 10.2471/BLT.23.030123. PMID: 36593776; PMCID: PMC9795384.

4:  Schou MD, Søgaard OS, Rasmussen TA. Clinical trials aimed at HIV cure or remission: new pathways and lessons learned. Expert Rev Anti Infect Ther. 2023 Jul-Dec;21(11):1227-1243. doi: 10.1080/14787210.2023.2273919. Epub 2023 Nov 8. PMID: 37856845.

5:  Papadakos SP, Mazonakis N, Papadakis M, Tsioutis C, Spernovasilis N. Pill versus vaccine for COVID-19: Is there a genuine dilemma? Ethics Med Public Health. 2022 Apr;21:100741. doi: 10.1016/j.jemep.2021.100741. Epub 2021 Nov 23. PMID: 34841029; PMCID: PMC8608621.

6:  Tanne JH. Royalty payments to staff researchers cause new NIH troubles. BMJ. 2005 Jan 22;330(7484):162. doi: 10.1136/bmj.330.7484.162-a. PMID: 15661767; PMCID: PMC545012.

7:  Mehellou Y, De Clercq E. Twenty-six years of anti-HIV drug discovery: where do we stand and where do we go? J Med Chem. 2010 Jan 28;53(2):521-38. doi: 10.1021/jm900492g. PMID: 19785437.

8:  Burke RV, Distler AS, McCall TC, Hunter E, Dhapodkar S, Chiari-Keith L, Alford AA. A qualitative analysis of public health officials' experience in California during COVID-19: priorities and recommendations. Front Public Health. 2023 Sep 13;11:1175661. doi: 10.3389/fpubh.2023.1175661. PMID: 37771831; PMCID: PMC10525347.

9:  Ward JA, Stone EM, Mui P, Resnick B. Pandemic-Related Workplace Violence and Its Impact on Public Health Officials, March 2020‒January 2021. Am J Public Health. 2022 May;112(5):736-746. doi: 10.2105/AJPH.2021.306649. Epub 2022 Mar 17. PMID: 35298237; PMCID: PMC9010912.

 10:  Royster J, Meyer JA, Cunningham MC, Hall K, Patel K, McCall TC, Alford AA. Local public health under threat: Harassment faced by local health department leaders during the COVID-19 pandemic. Public Health Pract (Oxf). 2024 Jan 24;7:100468. doi: 10.1016/j.puhip.2024.100468. PMID: 38328527; PMCID: PMC10847788.